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Longeveron Inc. Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results -- Full results from ELPIS I trial published in European Heart Journal Open - -- First patient to be randomized in

Key Takeaway: Longeveron Inc. provided a corporate update, announcing progress in its clinical trials and reporting financial results for the fourth quarter and full year 2022. The company's pivotal ELPIS I trial data was published in the European Heart Journal Open. Despite challenges such as reduced revenue and increased net losses, Longeveron remains optimistic, emphasizing advancements in its product Lomecel-BTM. They anticipate sufficient funds to maintain operations through the first half of 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful publication of ELPIS I trial results in a reputable journal.
  • Progress reported in ongoing clinical trials for Lomecel-BTM.
  • Financial outlook suggests sufficient cash to support operations into mid-2024.
  • Increased participation in clinical trials as travel restrictions eased.

CONCERNS & RISKS

  • Overall revenue slightly decreased in Q4 2022 compared to Q4 2021.
  • Significant net loss recorded for both Q4 2022 and full year 2022.
  • Grant revenue dropped markedly, indicating funding challenges.
  • Increase in R&D expenses but not fully covered by grants.

Full Press Release Details

Longeveron Inc. Provides Corporate
Update and Reports Fourth Quarter and Full Year 2022 Financial Results
-- Full results from ELPIS I trial published
in European Heart Journal Open -
-- First patient to be randomized
in Japan Aging-Related Phase 2 study in Q1 -
-- Conference call scheduled for 8:30 a.m. ET
Miami, Florida -March 10, 2023-
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative
medicines for unmet medical needs, today provided a business update and reported its financial results for the fourth quarter and full
"Longeveron had a productive 2022, executing
on multiple key milestones as we continued to advance Lomecel-BTM for multiple indications," said Wa'el Hashad,
Chief Executive Officer. "Earlier this year, the full data from our ELPIS I trial of Lomecel-BTM for infants with HLHS
was published in European Heart Journal Open. We are excited to continue advancing this opportunity through our ongoing Phase 2
ELPIS II trial. We have also made progress with our Japan Aging-Related Phase 2 study. We look forward to building on this progress through
Business Highlights and Anticipated Milestones:
Lomecel-BTM for Hypoplastic Left
Heart Syndrome (HLHS):
Lomecel- BTM for Aging-Related Frailty:
Lomecel-BTM for Alzheimer's
Financial Results for Fourth Quarter and Full
Year Ended December 31, 2022 and 2021
Revenue: Revenue in the fourth
quarter 2022 was $0.1 million compared to $0.2 million in the same period in 2021. The difference was primarily due to a decrease in clinical
trial revenue during the fourth quarter 2022. During the fourth quarter 2022, fewer participants decided on having the treatment as compared
Revenue for full year 2022 was $1.2
million compared to $1.3 million in 2021. Clinical trial revenue was $0.9 million for 2022 compared to $0.7 million for 2021, an increase
of $0.2 million, or 29%. Participation increased in 2022 as compared to 2021 as the effects of travel restrictions due to Covid-19 decreased.
Grant revenue was $0.3 million for 2022 compared to $0.6 million for 2021, a decrease of $0.3 million, or 53%, which was primarily due
to a reduction in grant funds available due in part to the completion of some grant-funded clinical trials.
R&D Expenses: Research and
development expenses in the fourth quarter of 2022 were $3.2 million compared to $1.7 million for the same period in 2021. The increase
of $1.5 million, or 88%, was primarily due to an increase in research and development expenses related to the completion of clinical trials
that were not reimbursable by grants. R&D Expenses for full year 2022 were $9.4 million compared to $7.1 million for 2021. The increase
of $2.3 million, or 32% was primarily due to an increase in research and development expenses related to the completion of clinical trials
that were not reimbursable by grants; The increase was offset by a decrease in equity-based compensation allocated to research and development
expenses, which decreased from $2.2 million in 2021 to $1.1 million in 2022.
G&A Expenses: General and
administrative expenses in the fourth quarter of 2022 were $1.6 million compared to $2.1 million for the same period in 2021. The decrease
of approximately $0.5 million, or 24%, was primarily related to a decrease in equity based compensation expenses and professional fees.
G&A Expenses for full year 2022 were $8.1 million compared to $9.7 million for 2021. The decrease of approximately $1.6 million, or
16%, was primarily related to a decrease of $3.0 million in equity-based compensation expenses allocated to general and administrative
expenses. However, employee benefit expenses increased by $0.5 million, which included a $0.4 million increase in expenses related to
employee recruitment and insurance and professional fees increased by $0.2 million.
Expenses: Selling and marketing expenses in the fourth quarter of 2022 and 2021 were $0.3 million. Selling and marketing
expenses for full year 2022 were $1.0 million compared to $1.2 million for 2021. The decrease of $0.2 million, or 17%, was primarily
due to a decrease in digital marketing expenses. Selling and marketing expenses consists primarily of investor and public relations
expenses. Further and as disclosed in Note 13. Reclassification of Prior Year Presentations, on the Form 10-K, during 2021, $0.9
million in expenses related to investor and public relations was recorded as general and administrative expenses and was
reclassified as selling and marketing expenses as they were in 2022.
Net Loss: Net loss was $4.5
million in the fourth quarter of 2022 compared to $4.1 million for the same period in 2021. Net loss for full year 2022 was $18.8 million
compared to $17.0 million in 2021.
Per Share: Net loss per share
was $0.21 in the fourth quarter of 2022 compared to $0.20 for the same period in 2021. Net loss per share for full year 2022 and 2021
Cash and Short Term Investments:
Cash and short-term investments was $19.6 million compared to $35.0 million as of December 31, 2022 and 2021, respectively. The decrease
in cash period over period was the result of use of funds for operations. During 2021, we received gross proceeds from our initial public
offering in February 2021 and our subsequent private placement offering in December 2021 of over $49.6 million.
Based on the Company's current operating
plan and financial resources, we believe that our existing cash and short-term investments will be sufficient to cover expenses and capital
requirements into first half of 2024.
Conference Call and Webcast
Management will host a conference call today at
8:30 a.m. ET to discuss the Company's fourth quarter and full year 2022 financial results and provide a business update.
U.S. Dial-in Number: 833 470 1428
Canada Dial-in Number: 833 950 0062
Global Dial-In Numbers
U.S. Replay Dial-in Number: 866 813 9403
All Other Locations Dial-in Number: +44 204 525
An audio webcast of the call may also be accessed
from the Investors' page of the Longeveron website at www.longeveron.com. A replay of the call will be available on the Longeveron
website shortly after completion of the call.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology
company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is
Lomecel-B , an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult
donors. Lomecel-B has multiple mechanisms of action encompassing pro-vascular, pro-regenerative, anti- inflammatory, and
tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently
advancing Lomecel-B through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer's
Disease, and Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com.
Forward-Looking Statements
Certain statements in this press release that
are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future performance and economic conditions,
and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made
herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects,"
"may," "looks to," "will," "should," "plan," "intend," "on condition,"
"target," "see," "potential," "estimates," "preliminary," or "anticipates"
or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects.
Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this
release include, but are not limited to, statements about the ability of Longeveron's clinical trials to demonstrate safety and
efficacy of the Company's product candidates, and other positive results; the timing and focus of the Company's ongoing and
future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity
for the Company's product candidates, including its estimates of the number of patients who suffer from the diseases being targeted;
the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic
effects of the Company's product candidates; the Company's ability to obtain and maintain regulatory approval of its product
candidates; the Company's plans relating to the further development of its product candidates, including additional disease states
or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; the Company's
plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and

Frequently Asked Questions

What is Longeveron Inc. focused on?

Longeveron Inc. develops regenerative medicines for unmet medical needs.

When was the ELPIS I trial data published?

Full results from the ELPIS I trial were published in early 2023.

What are Lomecel-B's potential applications?

Lomecel-B has potential applications in HLHS, Alzheimer's, and aging-related frailty.

How was the revenue for 2022 compared to 2021?

Revenue for 2022 was $1.2 million, slightly down from $1.3 million in 2021.

What will be discussed in the conference call?

The call will cover the fourth quarter and full year 2022 financial results.

Last updated: Mar 10, 2023